Vascular access device

ABSTRACT

An access device for placing a medical article within a body space includes a needle, a dilator, and a sheath. The dilator can be coaxially and slideably disposed about the needle, and the sheath can be coaxially and slideably disposed about the dilator. The access device can further include a inner member coaxially disposed between the needle and dilator. The needle can include a fenestration in fluid communication with a space between the needle and inner member. When the needle punctures a blood vessel, the fenestration allows blood to flow into the space between the needle and inner member to provide a visual indicator to a physician or healthcare professional that the needle is in a vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 15/232,144, filed Aug. 9, 2016, which is a divisional application ofU.S. application Ser. No. 14/207,120, filed Mar. 12, 2014, now U.S. Pat.No. 9,566,087, which claims the priority benefit of U.S. ProvisionalPatent Application Ser. No. 61/799,992, filed Mar. 15, 2013, theentirety of each is hereby expressly incorporated by reference herein.

BACKGROUND Field

The present disclosure is generally directed to access devices forintroducing and/or delivering a medical article (such as, for example, acatheter, cannula, sheath, etc.) into a body space, such as, forexample, an artery, vein, vessel, body cavity, or drainage site, andmore specifically, to a distal tip section of such devices.

Description of the Related Art

Various medical devices, for example, catheters, cannulas, sheaths,etc., are often introduced into a patient, for example, in an artery,vein, body cavity, or drainage site, to deliver fluids to or withdrawfluids from the patient. For example, a catheter or vascular sheath canbe introduced into a patient's blood vessel using the Seldinger or amodified Seldinger technique. These techniques involve inserting anaccess needle into the patient's blood vessel and then inserting aguidewire through the needle and into the vessel. A dilator and sheathin combination or separately are inserted over the guidewire throughtissue into the vessel. The needle can be removed before or afterinserting the dilator and sheath. The dilator and guidewire are thenremoved and discarded. The sheath can be left in the vessel, forexample, to deliver medical fluids to the patient, or a catheter orother medical article can be inserted through the sheath into the vesselto a desired location.

Various access devices for performing the Seldinger or a modifiedSeldinger technique are known. Some access devices provide the needle,dilator, and/or sheath coaxially disposed about one another. Some suchdevices provide mechanisms for confirming vascular access.

SUMMARY

The access devices described herein advantageously provide improvedmechanisms form confirming vascular access.

In some embodiments, an access device for placing a medical articlewithin a body space includes a needle, a dilator coaxially disposedabout the needle, and a inner member coaxially disposed between theneedle and the dilator. The needle includes a fenestration near a distalend of the needle. A distal end of the dilator is positioned distal tothe fenestration of the needle. A distal end of the inner member ispositioned distal to the fenestration and proximal to the distal end ofthe dilator. A space between an outer diameter of the needle and aninner diameter of the inner member defines a blood flash channel influid communication with the fenestration to allow blood to flow from aninterior of the needle through the fenestration to the blood flashchannel when the needle punctures a blood vessel.

In some embodiments, an access device for placing a medical articlewithin a body space includes a needle, a dilator, and a inner member.The needle includes a cylindrical body extending proximally along aneedle lumen from a distal opening to a fenestration. An outer surfaceof the cylindrical body is disposed at a radius r₁ from the centrallongitudinal axis of the needle lumen. The dilator includes acylindrical body extending proximally along a dilator lumen. An insidesurface of the dilator is disposed at a radius r₂ from the centrallongitudinal axis of the dilator lumen, and a portion of the cylindricalbody of the dilator is configured to be disposed about the needle distalto the fenestration. The inner member includes an inner portion, anouter portion, and a dimension defined therebetween. The dimension isless than r₂−r₁ such that the inner member can be positioned in a flashchannel between the needle and the dilator.

In some embodiments, a sheath assembly includes a sheath body, a hub,and a valve including an annular member and a sealing member. The sheathbody includes a generally flexible tubular structure, a proximal end,and a distal end and defines a longitudinal axis. The hub is coupledwith the proximal end of the sheath body, and the sheath body and hubhave aligned openings forming a passage therethrough. The annular memberof the valve is disposed against a surface of the hub facing the sheathbody and includes an opening therethrough. The sealing member of thevalve has an engagement portion coupled with a structure of the sheathassembly disposed generally between the surface of the hub and thedistal end of the sheath body. The sealing member also has a sealportion projecting into sealing engagement with the opening in theannular member in a sealing position and disposed away from the openingin the annular member in an open position.

In some embodiments, a sheath assembly includes a sheath body and hub.The sheath body includes a generally flexible tubular structure, aproximal end, and a distal end, and defines a lumen along a longitudinalaxis. The hub is coupled with the proximal end of the sheath body andhas a passage therethrough. The sheath assembly further includes a softpolymeric diaphragm coupled with a distal face of the hub. The diaphragmprovides fluid communication between the lumen and the passage when openand has a proximal face configured to seal against a device disposed inthe passage, diaphragm and lumen of the sheath assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features, aspects, and advantages of theembodiments of the invention are described in detail below withreference to the drawings of various embodiments, which are intended toillustrate and not to limit the embodiments of the invention. Thedrawings comprise the following figures in which:

FIG. 1A is a perspective view of an embodiment of an access devicehaving a pre-loaded guidewire coaxially aligned with a needle, adilator, and a medical article such as a sheath.

FIG. 1B is a plan view of the embodiment depicted in FIG. 1A.

FIG. 2A is a plan view of the needle from FIG. 1A.

FIG. 2B is a side view of the needle from FIG. 1A.

FIG. 2C is a cross-sectional view taken along the lines 2C-2C in FIG.2A.

FIG. 2D is an enlarged plan view of a portion of the needle of FIG. 2A.

FIG. 3A is a plan view of the dilator from FIG. 1A.

FIG. 3B is a cross-sectional view taken along the lines 3B-3B in FIG.3A.

FIG. 4A is a plan view of the sheath from FIG. 1A and shows a sheath hubconnected to a proximal end of a sheath.

FIG. 4B is a cross-sectional view of the sheath from FIG. 4A taken alongthe lines 4B-4B in FIG. 4A.

FIG. 4C is a proximal end view of another embodiment of a sheath.

FIG. 4D is a plan view of the sheath of FIG. 4C.

FIGS. 4E and 4F are a side isometric view and an exploded side isometricview, respectively, of an embodiment of a sheath.

FIG. 4G is a side cross-sectional view of the sheath of FIG. 4E taken at4G-4G.

FIGS. 4H-4I are enlarged views of a section of the sheath of FIG. 4Gshowing a valve element in a closed and opened position, respectively.

FIGS. 4J-4L are enlarged views of a section of an embodiment of a valveelement.

FIG. 5A is a perspective view of the guidewire section from FIG. 1A andshows a guidewire hub connected to a proximal end of a guidewire.

FIG. 5B is a plan view of the guidewire section of the embodimentdepicted in FIG. 5A.

FIG. 6A is a perspective view of a track from FIG. 1A.

FIG. 6B is a plan view of the track in FIG. 6A and shows a lockingmechanism for locking the needle relative to the dilator.

FIG. 6C is a side view of the track in FIG. 6B.

FIG. 6D an enlarged perspective view of the locking mechanism from FIG.6B.

FIG. 7A is a plan view of the embodiment depicted in FIG. 1Aillustrating the insertion of the distal end of the access device into apatient.

FIG. 7B is an enlarged view of the embodiment depicted in FIG. 8Afocusing on the area of the access device adjacent to the patient.

FIG. 7C is an enlarged view of a portion of the embodiment depicted inFIG. 8B and illustrates a needle opening in hidden lines.

FIG. 7D is an enlarged cross-sectional view of a portion of theembodiment depicted in FIG. 7C and shows the needle opening orfenestration so as to allow fluid to flow from inside the needle to achannel formed between the needle and dilator.

FIG. 7E is an enlarged cross-sectional view of the embodiment depictedin FIG. 7C proximal to the needle opening along line 7E-7E.

FIG. 7F is a plan view of a distal portion of another embodiment of aneedle, with interior features in phantom.

FIG. 7G is a side view of the needle of FIG. 7F.

FIG. 7H is an enlarged cross-sectional view of the embodiment depictedin FIG. 7C distal to the needle opening along line 7H-7H.

FIG. 7I is an enlarged cross-sectional view of another embodiment of anaccess device showing portions of a needle hub, a dilator hub, and aninsert.

FIG. 7J is an enlarged cross-section view of the access device of FIG.7I, wherein an insert is not fully inserted.

FIG. 7K is an enlarged view of an insert of the access device of FIG.7I.

FIG. 8A is a side view of the embodiment depicted in FIG. 1Aillustrating the guidewire advanced from the needle tip in a distaldirection.

FIG. 8B is an enlarged view of the embodiment depicted in FIG. 8Afocusing on the area where the guidewire hub is locked to the needle hubwhen the needle hub is in the first position.

FIG. 9A is a side view of the embodiment depicted in FIG. 1Aillustrating the dilator and sheath being advanced distally relative tothe needle body from the position illustrated in FIG. 8A.

FIG. 9B is an enlarged bottom view of the embodiment depicted in FIG. 9Afocusing on the area where the needle hub is locked to the track whenthe needle hub is in the second position.

FIG. 10A is a side view of the embodiment depicted in FIG. 1Aillustrating the removal of the guidewire, needle body, and dilator fromthe sheath.

FIG. 10B is an enlarged view of the portion of the embodimentillustrated in FIG. 10A showing the needle tip covered by the dilatorduring removal of the guidewire, needle body, and dilator from thesheath.

FIG. 11A is a partial side view of an embodiment of an access deviceincluding an inner member.

FIG. 11B is a partial section view of the access device of FIG. 11A.

FIG. 12 is a perspective view of an embodiment of an access deviceincluding an inner member.

DETAILED DESCRIPTION

In various circumstances a physician may wish to introduce a catheter orsheath into a space within a patient's body, for example, a blood vesselor drainage site, to introduce fluids to the space or remove fluids fromthe space. Various access devices are known in the art. Examples of animproved access device are described in International Application No.PCT/US2012/051495, entitled “ACCESS DEVICE WITH VALVE,” filed Aug. 17,2012, the entire contents of which is incorporated by reference hereinand forms part of this specification. FIGS. 1A and 1B illustrate anaccess device 20 that can be used, for example, in performing theSeldinger or a modified Seldinger technique to introduce a catheter orsheath to a patient's blood vessel. While the access device is describedherein in the context of vascular access, the access device also can beused to access and place a medical article (e.g., catheter or sheath)into other locations within a patient's body (e.g., a drainage site) andfor other purposes (e.g., for draining an abscess).

The present embodiment of the access device is disclosed in the contextof placing an exemplary single-piece, tubular medical article into abody space within a patient. Once placed, the tubular article can thenbe used to receive other medical articles (e.g., catheters, guidewires,etc.) to provide access into the body space and/or be used to provide apassage way for introducing fluids into the body space or removing(e.g., draining) fluids from the body space. In the illustratedembodiment, the tubular medical article is a sheath or catheter that isconfigured primarily to provide a fluid passage into a vein. Theprinciples of the present invention, however, are not limited to theplacement of single piece sheaths or catheters, or to the subsequentinsertion of a medical article via the sheath or catheter. Instead, itwill be understood in light of the present disclosure that the accessdevice disclosed herein also can be successfully utilized in connectionwith placing one or more other types of medical articles, includingother types of sheaths, fluid drainage and delivery tubes, and single ormulti-lumen catheters directly in the patient or indirectly via anothermedical article.

For example, but without limitation, the access devices disclosed hereincan also be configured to directly or indirectly place central venouscatheters, peripherally inserted central catheters, hemodialysiscatheters, surgical drainage tubes, tear-away sheaths, multi-piecesheaths, PICC lines, IV lines, scopes, as well as electrical conduit forwires or cables connected to external or implanted electronic devices orsensors. As explained above, the medical articles listed above may bedirectly placed in the patient via the dilator, needle, and guidewire ofthe access device or subsequently placed within the patient via amedical article that was placed within the patient via the dilator,needle, and guidewire of the access device.

Further, the embodiments disclosed herein are not limited to co-axialinsertion of a single medical article. For example, two catheters may beinserted in the patient via an inserted sheath or a second catheter maybe inserted in the patient via an inserted first catheter. Further, inaddition to providing a conduit into the vessel or other body space, themedical article inserted via the dilator, needle, and guidewire can forma lumen that is in addition to the lumen(s) of the subsequently insertedmedical article. One skilled in the art can also find additionalapplications for the devices and systems disclosed herein. Thus, theillustration and description of the access device in connection with asheath (e.g., for micro puncture applications) is merely exemplary ofone possible application of the access device.

With reference to FIGS. 1A and 1B, an example embodiment of an accessdevice 20 includes a needle 22, a dilator 24, and a tubular sheath 26.In the illustrated embodiment, the access device 20 also includes aguidewire 28 and guidewire track 30. The dilator 24 can be coaxiallydisposed about the needle 22, and the sheath 26 can be coaxiallydisposed about the dilator 24. The access device 20 can be configured toallow for telescoping movement among the needle 22, dilator 24, andsheath 26.

With reference to FIGS. 2A-2D, the needle 22 includes a needle body 32and needle hub 34. The needle hub 34 is disposed on a proximal end ofthe needle body 32 at a proximal portion 52 of the needle 22. The needlehub 34 can include a locking structure 66 at a distal portion 61 of theneedle hub 34 to allow the physician or healthcare provider to lock theneedle hub 34 to a medical article such as a dilator hub 38 as describedin greater detail herein. The needle hub 34 can also include a lockingstructure at a proximal portion 60 of the needle hub 34 to allow thephysician or healthcare provide to secure (e.g., releasably secure)another medical article to the needle hub 34. The needle body 32terminates at a distal end near a distal portion 50 of the needle 22.The distal end of the needle body 32 can have a bevel tip 54.

The needle body 32 has a sufficiently long length to access a targetedsubcutaneous body space and has a sufficient gauge size to withstand theinsertion forces when accessing the body space without causing unduetrauma. For many applications, the needle body can have a length between3-20 cm, and more preferably between 3-10 cm. For example, to access abody space (e.g., a vessel) in the thorax of an adult human, the needlebody 32 preferably has a length of 7 cm or greater, and more preferablyhas a length of 9 cm or greater, and most preferably has a length of 9to 10 cm. The size of the needle preferably is 18 gauge or smaller, andmore preferably between 18-28 gauge, and most preferably between 18-26gauge for micro-puncture applications (e.g., peripheral IVs). Forapplications with a neonate, the length and gauge of the needle body 32should be significantly shorter and smaller, for example preferablybetween 3-4 cm and between 26-28 gauge. In some embodiments, the needle22 includes an echogenic portion that can be used in combination withultrasound to help position the needle in the desired location.

In some embodiments, the needle body 32 includes at least onefenestration or opening 56 near a distal end of the needle body 32. Thefenestration 56 extends, or provides a path, through the wall or side ofthe needle body 32. The fenestration 56 can allow for a fluid, such asblood, to flow into a space between a portion of the needle body 32 anda portion of the dilator 24 during use of the access device 20, creatinga “blood flash.” During blood flash, blood is observed flowing betweenthe needle 22 and dilator 24 to indicate to the physician or healthcareprovider that the tip 54 of the needle body 32 has punctured a bloodvessel. The fenestration 56 can have a variety of shapes andorientations on the needle body 32. For example, the fenestration 56illustrated in FIG. 2D has an oblong shape. However, the shape of theside opening 56 is not limited to the illustrated embodiment and may beround, oblong, square, or another shape.

With reference to FIGS. 3A-3B, the dilator 24 can include a dilator body36 and dilator hub 38. The dilator hub 38 can include a first lockingstructure 78 to engage the needle hub 34 and a second locking structure80 to engage with a sheath hub 42, described in greater detail herein.For embodiments of the access device 20 having a fenestration 56 in theneedle 22 to allow for blood flash, optical properties, such as thecolor, of the needle 22 and/or the dilator 24 can be selected to enhancethe contrast between the blood or other fluid and the needle 22 and/ordilator 24. To increase the visibility of the fluid as the fluid flowsbetween the needle 22 and the dilator 24, the dilator 24 can bemanufactured from a clear or at least somewhat transparent material withthe needle 22 having a color that contrasts with the color of the fluid.For example, the needle 22 can have a white or silver color to enhanceits contrast with red blood.

As shown in FIGS. 4A-4B, the sheath 26 can include a sheath body 40 andsheath hub 42. The sheath hub 42 can include a locking structure 94configured to engage, for example, the second locking structure 80 ofthe dilator hub 38. The sheath body 40 may be a single piece sheaththrough which a catheter or other medical article (e.g., a guidewire) isinserted into the vessel. In such an embodiment, the sheath body 40forms a conduit for insertion of the catheter or other medical article(e.g., a guidewire). In addition to providing a conduit, the sheath or aportion of the sheath can form a lumen that is in addition to thelumen(s) of the catheter. For example, an equivalent to a triple lumencatheter can be formed by inserting a dual lumen catheter through thesheath body 40 with the sheath body 40 itself forming a third lumen. Thesheath body 40 can be manufactured from a clear or at least somewhattransparent material to allow the physician or healthcare provider tosee blood flowing between the needle body 32 and dilator 24 through thesheath body 40.

In some embodiments, for example as shown in FIGS. 4C and 4D, the sheathcan be a splittable sheath 26A. For example, it may be advantageous toremove a portion of or the entire sheath body 40A depending on the typeof catheter or medical article that is to be inserted into the vesselafter employing the access device 20. For example, after the catheter orother medical article is inserted into the vessel, a portion of thesheath body 40A can be separated or peeled-away and removed to reduceclutter at the access site. A peel-away sheath can include perforations,serrations, skives, or other structures, or include other materials(e.g., PTFE with bismuth) to allow the physician or healthcare providerto remove easily a portion or the entire sheath body 40A.

In some such embodiments, the sheath hub 42A may comprise radiallyextending wings, handle structures, or tabs 43 to allow for easy releaseand removal of the sheath body 40 from other parts of the access device20. Tabs 43 can have any of a number of different shapes and/or surfacefeatures to facilitate them being gripped, and are not limited to thesubstantially T-shape shown. Tabs 43 are separable, to allow thesplittable sheath 40A to separate along one or more split lines, such asa predetermined split or separation line 45. The split line 45 canextend through either or both the sheath hub 42A and the sheath body40A. The split line(s) can extend generally parallel to one or morelongitudinal axes defined by the sheath body 40A and/or sheath hub 42A,but in some embodiments, the split line(s) can extend substantiallynon-parallel. As illustrated, splitting the sheath 26A along the splitline 45 can separate the sheath 26A into two or more symmetrical orasymmetrical portions (e.g., halves). The sheath 26A can include similaradditional features described herein for sheath 26. In some embodiments,sheath 26A can include similar features that are also configured to beseparable into one or more portions along split line 45. For example,sheath 26A can have a separable lip 95A, allowing engagement of sheath26A with other elements described above, such as the dilator 24, whileallowing separation along split line 45. Additional embodiments of asplittable sheath body and/or hub that can be employed with sheath 26Aare shown and described, for example, in FIGS. 23A-23B, and thecorresponding supporting text (e.g., paragraphs [0223]-[0227]), of PCTInternational Patent Application No. PCT/US2010/034609, filed May 12,2010, hereby incorporated by reference in its entirety herein. In someapplications, the wings are sized to provide the healthcare providerwith leverage for breaking apart the sheath hub 42. The sheath hub 42and/or the sheath body 40 may comprise two or more portions (e.g.halves) connected by a thin (e.g., frangible) membrane. The membrane canbe sized to hold the two or more portions of the sheath hub 42 and/orsheath body 40 together until the healthcare provider decides to removethe sheath hub 42 and/or sheath body 40 from the access device. Thehealthcare provider manipulates the wings to break the membrane andsever one or more portions of the sheath hub 42 into separate orpartially separated pieces.

FIGS. 4E-4I illustrate another embodiment of a sheath that can be usedwith the dilators, needles, guidewires, and other elements describedherein in a similar manner to the previously described sheaths is sheath26B. Sheath 26B can include a sheath body 40B and a sheath hub 42B, withan inner cavity 241 extending through or along a portion of sheath body40B and/or sheath hub 42B (e.g., along one or more longitudinal axesthereof). Sheath hub 42B can extend from a proximal end of sheath body40B. Sheath body 40B and/or sheath hub 42B can be optionally splittablealong one or more split lines 45. In some embodiments, sheath body 40Band/or sheath hub 42B can be splittable along two or more split lines45, to form two or more separable sections or halves, such as sheath hubsections 261 and 271. The embodiments of sheath 26B, including body 40Band hub 42B, can be generally similar to the embodiments of sheaths,sheath bodies, and/or sheath hubs discussed elsewhere herein.

With reference to FIGS. 4F-4I, sheath 26B can include a valve element240 configured to substantially seal a portion of inner cavity 241.Valve element 240 can include a resilient plate 242 supporting a sealingelement 243. The resilient plate 242 can be supported by a portion ofthe sheath body 40B and/or hub 26B such that a portion (e.g., a sealingportion 264) of the resilient plate 242 can extend (e.g., radiallyinwardly) into and substantially seal the inner cavity 241. Valveelement 240 can be positioned between a proximal portion 244 of innercavity 241 and a distal portion 245 of inner cavity 241, such thatproximal portion 244 and distal portion 245 can be substantially sealedwith respect to each other. Portions 244, 245 can comprise any of avariety of sizes and shapes, and are shown with an approximatelycircular cross-sectional shape for illustrative purposes only. In thedepicted embodiment, proximal portion 244 of inner cavity 241 comprisesat least a region having a cross-sectional area that is less than distalportion 245, to facilitate sealing of valve 240 against portion 244,while allowing valve 240 to flex and move distally into distal portion241, as described further herein. In this arrangement, the valve 240 canbe configured to substantially inhibit flow through the inner cavity 241in a proximal direction, while not substantially inhibiting the passageof articles such as a dilator or needle through the cavity.

Valve element 240 can be adapted to flex or move between a closed, orsubstantially sealed position (for example, as shown in FIGS. 4G and4H), and an open, or substantially unsealed position (for example, asshown in FIG. 4I), through flexation or flexing of resilient plate 242.Valve element 240 can move between an open and closed position throughpassage of a fluid (or gas), a device, or through an operation by a user(for example, using an external lever or other device attached toresilient plate 242). In the closed position, a sealing surface 266 on aproximal surface of the sealing element 243 can contact or otherwiseengage with a corresponding sealing surface 267 on a distal surface ofat least one of the splittable sheath body and hub 40B, 42B. Theinteraction of the sealing surfaces 266 and 267 can inhibit passagethrough the cavity 241 in the proximal direction. Notably, pressureagainst the valve element 240 in a proximal direction can press thesealing surfaces 266 and 267 further together. In some embodiments, thismechanism can be sufficiently resilient to withstand pressuresassociated with human blood vessels to prevent a loss of blood throughthe valve. In some embodiments, the sealing element 243 includes araised portion, such as substantially dome-shaped portion 278. Thedome-shaped portion 278 can prevent or reduce the likelihood of contactbetween the sealing surface 266 and a device 263, when the device 263 isextended through cavity 241. For example, if sheath 26B is stored with adevice extended through the cavity 241, for example, a dilator 24 asdescribed herein, if the device sets or sticks to another portion of thesheath 26B, it will do so to the raised portion 278, and not to aportion of the sealing surface 266. As such, the raised portion 278 canprevent damage to the sealing surface 266 of the sealing element 243 byextended forceful contact with the device 263, and thus extend thesealing capability and life of the valve element 240.

In some embodiments, the resilient plate 242 is configured such that thesealing surface 266 of the sealing element 243 is biased or preloadedagainst sealing surface 267 of the splittable sheath body and/or hubsuch that valve 240 is preloaded in the closed position. This biasingcan enhance the above-described inhibition of passage of matter in theproximal direction. Additionally, the biasing can help the valve element240 inhibit passage of matter such as the flow of fluid or gas (e.g.,blood flash, or air) or passage of a device in a distal direction (e.g.,longitudinally) within cavity 241. For example, the bias towards theclosed position can be strong enough to resist a force (or crackingpressure) in the distal direction to open the valve element 240. In someembodiments, the preload or bias of valve element 240 can be sufficientto prevent gas from being drawn distally through cavity 241, and into apatient due to, for example, negative pressure created by a human duringa normal pulse. Notably, drawing gas into a blood vessel can causeserious health effects such as an embolism.

Resilient plate 242 can comprise any of a variety of materials withsufficient rigidity to support sealing element 243 and substantiallyseal inner cavity 241, and with sufficient flexibility to allow valveelement 240 to flex or move between the open and closed positionsdescribed herein. Resilient plate 242 can comprise a bio-compatiblemetal or plastic, or various composites or combinations thereof.Preferably, resilient plate 242 can comprise a material with reducedsusceptibility to cold-setting, such that a needle, dilator, catheter,or other medical article can be extended through cavity 241, with valveelement 240 in an open position, as described above, and packagedtogether for a period of time within the sheath 26B, withoutcompromising the valve features (e.g., its flexibility and ability toseal cavity 241 when in a closed position). In some embodiments,resilient plate 242 can comprise, Nickel, Titanium, and/or steel (e.g.,stainless steel, spring steel, etc.), or various alloys or combinationsthereof. In some embodiments, resilient plate 242 comprises NiTi(Nitinol), or NiTi SE. In some embodiments, the resilient plate 242 cancomprise a shape-memory alloy to facilitate its movement between anopened and closed position and to prevent cold-setting for extendedperiods of time such as 2 years.

Sealing element 243 can comprise any of a variety of materials that cansubstantially seal inner cavity 241 when in contact with or biasedagainst sealing surface 267. In some embodiments, sealing element 243can comprise metal, plastic, rubber, or other suitable biocompatiblematerials such as polyisoprene, silicone, polyurethane, or other elasticpolymers. In some embodiments, the Shore A hardness of sealing element243 can be within a range of approximately 5 to 90, or in someembodiments, 10 to 70, or in some embodiments, approximately 15 to 50,or in some embodiments, approximately 30. In some embodiments, thesealing element 243 can be coated or include other surface treatments,such as a siliconized surface to facilitate low-friction sliding ofvarious elements along its surface (such as device 263). Even further,in some embodiments the resilient plate 242 and the sealing element 243can be formed of the same material, such that the valve element 240 canoptionally be a single unitary piece.

Resilient plate 242 and/or element 243 can be formed in a number ofdifferent ways, such as molding (e.g., injection), stamping and thelike, and can be formed separately or integrally. Resilient plate 242and sealing element 243 can be attached to each other in a variety ofways, such as with adhesive, bonding (e.g., ultrasonic, thermal, etc.),fasteners, overmolding, and the like. A primer or non-stick coating orsurface treatment can be applied to plate 242 and/or sealing element 243to facilitate their attachment to each other during the manufacturingthereof. In some embodiments, a plurality of plates 242 and/or elements243 can be formed in a single molding or stamping step, with severabletabs to allow the plates 242 and/or elements 243 to be usedindividually. With respect to the bending properties of the resilientplate 242, described above, in some embodiments the resilient plate 242can be pretreated to have certain mechanical characteristics prior toits combination with the sealing element 243.

The valve element 240, as depicted by way of the resilient plate 242,can attach to the sheath 26B by a variety of means. In some embodimentsit can be glued or bonded to the sheath 26B. In other embodiments, theresilient plate 242 can attach to the sheath 26B by molding orovermolding. In further embodiments, the resilient plate 242 can bemolded integrally with the sheath 26B (or a portion thereof such as thesheath hub half). When formed integrally, it may be desirable to givethe hub 42B or body 40B a substantially greater thickness than theresilient plate 242, such that the hub or body maintains a higherrigidity. In other embodiments the resilient plate 242 can attach to thesheath 26B by a mechanical compression, such as where the sheath hub 42Bor body 40B includes a groove that receives the plate, and allows it tobe press-fit into position.

Resilient plate 242 can be attached to various portions of sheath hub42B and/or body 40B. In some embodiments, the sheath hub 42B and/or body40B can comprise two or more separate pieces that are positioned andattached with respect to each other such that a portion of resilientplate 242 is clamped between a portion of sheath hub 42B and/or body40B. As best shown in FIGS. 4F, 4H, and 4I, sheath hub 42B can comprisea proximal portion 48 and a distal portion 49, configured to engage witheach other such that the valve element 240, by way of a mounting portion265 of the resilient plate 242, can be supported or clamped therebetweenwithin a groove or gap 274 (as shown in FIG. 4I). Portions 48, 49 cancomprise any of the materials described herein generally for sheath 26Band other components thereof, such as sheath hub 42B and sheath body40B. In one embodiment, portion 48 comprises ABS plastic. In oneembodiment, portion 49 comprises a K resin. Portions 48, 49 can engagewith each other using any of a variety of attachment means and methodsknown or described herein, such as bonding, adhesive (e.g., solvents),and the like.

The valve element 240, and resilient plate 242, can be attached to oneor more sections of sheath hub 42B and/or body 40B that separate alongline(s) 45. Preferably, resilient plate 242 is attached to only oneseparable section of sheath 26B, such as sheath hub section 261, tofacilitate the separation of valve 240 from sheath hub section 271during the splitting of sheath 26B. Additionally, plate 242 can beattached to only one separable section of sheath 26B to facilitate theflexing and movement of resilient plate 242 and sealing element 243within inner cavity 241. In other embodiments, where the valve element240 is attached to multiple separable portions of the sheath hub 42Band/or body 40B, the valve element 240 can also be separable by similarstructures.

FIGS. 4J-4L show further embodiments that include an annular member 268and a resilient plate 242A and sealing element 243A. The plate 242A andsealing element 243A can be similar to the resilient plate 242 andsealing element 243 shown in FIGS. 4F-4I and described herein. Theannular member 268 can function like an O-ring in some respects. Asshown, the annular member 268 includes a central bore 269 configured toreceive the domed-shaped portion 278A of the sealing element 243A whenthe valve is in a closed position. A top surface of the annular member268 tapers so that the annular member is thinner proximate the bore 269than at a location outward of the bore 269, e.g., at the outer edge. Thetaper can be downwardly from an upper surface in some embodiments. Abottom surface of the annular member 268 can be substantially straightor flat. The annular member 268 is placed against the sealing surface267 so that in a closed position, the sealing element 243A seals againstthe annular member 268 rather than the sealing surface 267. The annularmember 268 can be made of a relatively soft material, and can be thinenough to tear during splitting of the sheath 26B. The annular member268 can advantageously compensate for possible molding imperfectionsand/or misalignment in the manufacture and assembly of the sheath hub,for example, due to being constructed from a relatively soft andcompliant material. The annular member 268 also advantageously reducesthe size of the aperture to be sealed by the sealing element 243Acompared to the sealing surface 267, which can produce a greater vacuumhold to bias the sealing element 243A in a closed position with the samespring pre-loading force of the resilient plate 242A. Additionally, theannular member 268 can act as a seal around a device introduced into thepatient through the sheath 26B to maintain a seal when the valve 240 isin an open position to accommodate the device. The annular member 268can therefore act as a seal independent of the sealing element 243A. Insome embodiments, the annular member 268 can stretch to accommodateand/or conform to various devices that can be introduced through thesheath 26B.

In some embodiments, the sealing element 243A can be made of arelatively hard material, for example, polyurethane or polycarbonate.Inclusion of a relatively soft annular member 268 can advantageouslyallow the sealing element 243A to be made of a relatively hard materialbecause the more compliant annular member 268 can compensate for moldingimperfections, misalignment, and the like for which a relatively hardsealing element 243A may not be able to compensate as effectively. Therelatively hard material can advantageously reduce possible damage tothe resilient plate 242A. Additionally, with a sealing element 243A madeof a relatively softer material, for example, silicone, the resilientplate 242A may bend to some extent anywhere along its length when thevalve is opened. With a sealing element 243A made of a relatively hardermaterial, bending of the resilient plate 242A may be relatively morelimited to a pivot axis 270, which can reduce possible damage and/orwear to the resilient plate 242A. The relatively hard material can alsobetter resist tearing and/or other wear. Such tearing or wear canadversely affect the effectiveness of the seal or expose sharp portionsof the resilient plate 242A, which can cut or otherwise damage otherinstruments, for example a dilator 24 as described herein, inserted intoand/or removed from the sheath 26B through the valve 240.

As shown in FIGS. 5A-5B, the guidewire 28 can include a guidewire body44 and guidewire hub 46. The guidewire hub 46 can have a structurecorresponding to a coupling section 290 on the guidewire track 30, shownin FIGS. 6A-6D, to releasably connect the hub 46 to the track 30. Theguidewire track 30 can also include a distal locking member 124 toconnect the track 30 to the dilator hub 38, and a locking mechanism 128for the needle hub 34.

The access device 20 can be packaged pre-assembled as shown in FIGS. 1Aand 1B, with the guidewire 28 coaxially disposed within the needle 20,the guide wire hub 46 secured to the track 30, the needle coaxiallydisposed within the dilator 24, the needle hub 34 locked to the dilatorhub 38, the guidewire track 30 attached to the dilator hub 38, thedilator 24 coaxially disposed within the sheath 26, and the dilator hub38 locked to the sheath hub 42. In some alternative embodiments, thesplittable sheath 26A is packaged uncoupled from the remainder of theaccess device 20. Prior to use, the physician or healthcare provider caninsert the needle body 32 and dilator body 36 into the sheath 36A, andadvance the needle and dilator distally or the sheath proximallyrelative to one another until the sheath hub 42 locks to the dilator hub38.

In use, the needle body 32 is inserted into a blood vessel 148 or otherbody site as shown in FIGS. 7A-7B. FIGS. 7C-7E illustrate an embodimentof the access device at this stage of use, wherein a channel is formedbetween the needle and the dilator, to allow, for example, blood to flowduring a blood flash. Referring to FIGS. 7C-7G, the needle body 32includes one or more fenestrations 56 that allow blood to flow throughthe sidewall of the needle body 32 and into a space between the needlebody 32 and the dilator shaft 36. One or more optional ridges 176 (e.g.,two ridges 176 extending from the dilator shaft 36 are shown in theillustrated embodiment) can extend between the needle body 32 and thedilator shaft 36. The ridges 176 can define the sides of at least onechannel 256 extending along a length of the needle body 32. In someembodiments additional channels 256 can be formed with additional ridgesor other features. In some embodiments, the ridges 176 can includelongitudinal gaps, to allow circumferential or transverse flow betweenadjacent channels formed by the ridges 176. In other embodimentschannels 256 can be formed with a protruding ridge, or without aprotruding ridge such as with a depression(s) or with a concentric gap.Channel 256 can be formed with protruding ridges (as shown) ornon-protruding recessed grooves or flowpaths on the inner surface of thedilator shaft 36 and/or the outer surface of the needle body 32. Channel256 can be formed without protruding ridges and/or grooves, and cansimply comprise the annular space formed between needle body 32 anddilator shaft 36. Although the channel 256 is depicted as straight, itcan also form other patterns such as a helix or another shape wrappingabout the access device. Further, where multiple channels are presentthey can form intersecting helices, parallel helices, or other patterns.In other embodiments, a distance between the needle body 32 and adilator shaft 36 (e.g. where the inner diameter of the dilator shaftexceeds the outer diameter of the needle body) can generally define aspace, or a generally annular space, similar to the space created by thechannels 256.

In some embodiments, the access device 20 includes features to vent theflash channel 256. Examples of various vents can be found in PCTInternational Patent Application No. PCT/US2012/051495, filed Aug. 17,2012, which is incorporated by reference in its entirety herein. In someembodiments, venting can be provided at least partially through aninsert 51 between the dilator hub 38 and needle hub 34, as shown inFIGS. 7I-7K. In some embodiments, an additional piece such as the insert51 can facilitate the provision of certain desirable dimensions,materials, and other design features that might not be otherwisepossible or economical. For example, it may be desirable for a middleportion of the dilator shaft 36 to have an inner diameter substantiallylarger than the outer diameter of the needle body 32 near a needlefenestration. This difference in diameters can create a space thatallows a body fluid to flow between the two (such as in the channel 256)from the fenestration. However, in some embodiments it may also bedesirable to provide the dilator shaft 36 with a smaller inner diameternear the dilator's distal tip. In further embodiments it may bedesirable to provide a proximal portion of the dilator 424 that also hasa smaller diameter to hinder the flow of a body fluid such as bloodproximally while still allowing the venting of gases. This venting canfacilitate the drawing of a body fluid into the space, cavity, orchannel. However, it may be difficult to manufacture a dilator 24 withsmall inner diameters at its proximal and distal ends, and a large innerdiameter in a middle portion.

The embodiment depicted in FIGS. 7I-7K provides venting with theassistance of an insert 51. The insert 51 can be disposed within aproximal opening 107 of the dilator hub 38. The proximal opening 107 canbe configured to also receive a distally protruding portion 109 of theneedle hub 34. In some embodiments the insert 51 can be press-fit intothe dilator hub 38, while in other embodiments it can be loosely slidonto the needle body 32 (e.g., prior to combination with the dilator).

As best depicted in FIG. 7K, the insert 51 defines a through-hole 101that can slidingly receive the needle 22 (or another needle describedherein), e.g. along the needle body 32. Further, as depicted, the insert51 can be substantially circular, or donut-shaped, allowing flexibilityin its rotational position within the dilator hub 38. However, in otherembodiments the insert 51 can be rotationally fixed within the dilatorhub 38, i.e., with a non-circular insert and a correspondingnon-circular receiving portion in the dilator hub 38.

Even further, the insert 51 can have particular dimensions to facilitatethe release of gases while hindering the release of body fluids. Forexample, the diameter of the insert's through-hole 101 can be onlyslightly greater than the outer diameter of the needle body 32, creatinga space or gap (not shown) between insert 51 and needle body 32, the gapsized to allow the release of gases but hinder the release of a bodyfluid. As best shown in FIGS. 7I and 7J, the gases can then flowproximally within the gap between insert 51 and needle body 32 and entera space 107, 108 between the needle hub 34 and the insert 51 within thereceiving portion or opening 107 of the dilator hub 38. From this space,the gases can then proceed to the ambient atmosphere in a passage 111defined between the needle hub 34 and the dilator hub 38. Notably,although in some embodiments the needle hub 34 and the dilator hub 38can connect via a luer connection that may prevent the passage of gases,additional mechanisms known in the art or described herein can alsoattach the two hubs. For example, in the depicted embodiment the needlehub 34 can include latch element 66 that can releasably hook to a ledgeportion or lip 77 of the dilator hub 38. Thus, components that mightotherwise form a luer connection between the two hubs can also besufficiently separated to allow the escape of gases without compromisinga connection between the hubs.

Further, the outer edge of the insert 51 can be shaped to substantiallymatch the receiving portion of the receiving portion of the dilator hub38 to form a seal between the two that at least hinders the escape of abody fluid therethrough. In some embodiments, a taper 105 within thedilator hub 38 (also used for a luer connection with a needle, asdiscussed above) can facilitate a seal between the insert 51 and thedilator hub. In some embodiments, the seal between the outer edge of theinsert 51 and the receiving portion 107 of the dilator hub 38 can alsobe impermeable to gases, forcing their passage through the through-hole101, as described above.

The insert 51 can also include a proximally projecting portion depictedas a ridge 103 along its proximal face, which can be of particularrelevance as shown in FIG. 7J. For example, if the insert 51 is askew,it may not completely insert into the dilator hub 38, leaving a gap 106between the insert 51 and a distal portion of dilator hub 38 withinopening 107, as depicted in FIG. 7J. Gap 106 could allow the insert 51to come into contact with the needle hub 34, potentially forming a seal,preventing the escape of gases through the insert's through-hole 101.Thus, in some embodiments, the insert can also include a ridge 103 withone or more grooves 104. The needle hub 34 can contact the ridge 103before contacting the rest of the proximal end of the insert 51,preserving a space therebetween. The one or more grooves 104 provide anopening or channel in the ridge 103 for gases to pass through, to thepassage 111 between the hubs 34, 38. In the depicted embodiment, morethan one groove can be provided to advantageously allow gases to passthrough in multiple directions. Thus, if sealing contact between theinsert 51 and the needle hub 34 is made on one side, gases can stillescape on the other side.

The blood flash channel 256 can have various thicknesses and spanangles. The thickness of the channel 256 can vary depending on thedimensions of the needle 22 and dilator 24. The channel 256 can have aspan angle Φ about the axis of the dilator 24 of about 30 degrees toabout 210 degrees or more, but preferably less than 360 degrees. Morepreferably, the channel 256 can have a span angle Φ of about 60 to 150.In the illustrated embodiment, the channel 256 spans 120 degrees. Thethickness and span angle Φ can be chosen so as to optimize the capillaryaction that occurs within the channel 256 as fluid (e.g., whole blood)enters the channel 256 as may further be selected based on the expectedpressure in the body cavity and viscosity of the liquid. Various graphsof test data illustrating how quickly a fluid is drawn up the surfacesof a channel within an access device are disclosed in PCT InternationalPatent Application No. PCT/US2011/024097, filed Feb. 8, 2011, which isincorporated by reference in its entirety herein.

The shape of the channel 256 described above and the resulting capillaryaction were optimized for use with whole blood as opposed to otherfluids having a different viscosity than whole blood (e.g. leukocytes,pus, urine, plasma). However, the shape of the channel 256 is notlimited to the disclosed shape and may be optimized for draining otherliquids, such as pus. Further, the shape of the channel 256 describedabove was optimized for peripherally located vessels where the pressurein the vessel enhances the capillary action and resulting blood flash aswell as for vessels located in the regions where the pressure may below. For example, in the thorax region of the body, the expectedpressure in the veins may be lower than in a peripherally located veinwhen the patient breathes. A different size of the channel for use ofthe access device 20 in other regions of the body may be employed takinginto account the expected pressure within the vessel or body cavity.

With reference to FIG. 7H, in a region of the access device 20 distal offenestration 56, the dilator shaft 36 is coaxially positioned tominimize an annular space 157 between the needle body 32 and the dilatorshaft 36 while still allowing relative movement of the needle body 32and the dilator shaft 36. The inner surface 152 of the dilator shaft 36need not, though it can, lie directly against the outer-surface 154 ofthe needle body 32. The annular interface 157 between the outer-surface154 of the needle body 32 and the inner surface 152 of the sheathdilator shaft 36 may be reduced in this region to inhibit the distalflow of blood or its constituents (or other fluids) from the opening 56in the needle body 32.

With reference to FIGS. 8A-8B, once the physician or healthcare providerhas located the needle 22 within the target blood vessel, the guidewire44 is inserted into the vessel 148 by advancing the guidewire hub 46distally until the guidewire hub 46 locks to the needle hub 34. Next,the dilator body 36 and sheath body 40 are inserted into the vessel 148by releasing the dilator hub 38 from the needle hub 34 and advancing thedilator 24 and sheath 26 distally relative to the needle hub 34 alongthe guidewire and needle as shown in FIGS. 9A-9B. The guidewire track 30also advances distally with the dilator hub 38, and the needle hub 34locks to the locking mechanism 128 of the track 30, preventing furthermovement of the needle hub 34. With reference to FIGS. 10A-10B, theguidewire 44 and dilator body 36 are removed from the vessel 148 leavingthe sheath body 40 properly inserted within the vessel 148.

For a physician or healthcare provider relying on blood flash to confirmthat the needle 22 has punctured a blood vessel, it is important for theblood flash to be visible and noticeable as soon as possible upon entryinto the blood vessel. Due to the relatively small diameter ofperipheral blood vessels, even a small delay in the appearance of theblood flash can result in the physician continuing to advance the needle22, possibly completely through the blood vessel. In some cases, alarger flash channel 256 (e.g., one associated with a larger Frenchdilator) can result in a slower blood flash because blood entering thechannel 256 has a larger volume to fill before traveling proximallyalong the outer surface of the needle. Various parameters, including thedimensions of the various components of the access device 20, can affectthe size of the flash channel 256 and speed of the blood flash. Aphysician or healthcare professional may want to place a relativelylarge sheath 26 in the vessel 148 in certain circumstances, for example,to deliver a large volume of fluid rapidly, to introduce other devicesor instruments into the vessel 148 via the sheath 26 (e.g., introduce aCentral Vascular Catheter (CVC)), to remove fluid or specimens from thevessel 148, or various other reasons. Therefore, some access devices 20include a relatively larger sheath 26 and therefore a relatively largerdilator 24, which can result in a larger flash channel 256 for a givensize of needle. For example, in an access device 20 having a 21 gaugeneedle body 32 and a 7 French dilator 24, a distance d₁ between an outerdiameter of the needle body 32 and an inner diameter of the dilator 24can be about 0.025 inches (in.). The dimension d₁ of this magnitudecorresponds to a larger than conventional cross-sectional surface areawhich can result in a blood flash that is slower than desired.

To reduce the size of the flash channel 256 and produce a faster bloodflash, the access device 20 can include an inner member 90, that iscoaxially disposed between the needle body 32 and dilator shaft 36, forexample as shown in FIGS. 11A and 11B, and that displaces blood or otherbody fluids between the needle body 32 and the dilator shaft 36. Adistal end of the inner member 90 is proximal to a distal end of thedilator shaft 36, but distal to the fenestration 56 in the needle body32. The inner member 90 can be positioned coaxially with the dilatorshaft 36. In particular, the inner member 90 can occupy some of thevolume defined between the inner surface of the dilator 36 and the outersurface of the needle body 32. The inner member 90 reduces the freevolume between these components to expedite the flash and, in someembodiments, defines a smaller flash volume between the needle body 32and the inner member 90. In a region of the access device distal offenestration 56, the inner member 90 can reduce and in some casesminimize an annular space between the needle body 32 and the innermember 90. An inner surface of a distal end portion of the inner member90 need not, though it can, lie directly against the outer surface ofthe needle body 32. In a preferred form, the distal end of the innermember 90 defines an orifice through which the needle body 32 passes ina manner of slip fit or slight interference fit. An annular interfacebetween the outer surface of the needle body 32 and the inner surface ofthe inner member 90 may be reduced in this region to inhibit the distalflow of blood or its constituents (or other fluids) from the opening 56in the needle body 32.

In embodiments of the access device including the inner member 90, theflash channel 256 is formed between the needle body 32 and the innermember 90 rather than between the needle body 32 and an inner surface ofthe dilator shaft 36, thereby reducing the cross-sectional area of,e.g., the dimension of, the flash channel 256 from d₁ to d₂ as indicatedin FIG. 11B. In some embodiments, the inner member 90 can reduce thethickness of the flash channel 256 to about one half or less than aboutone half, for example, about one fifth, about one tenth, or less thanone tenth, of the thickness of the flash channel 256 without the innermember 90. In some embodiments of the access device having a 21 gaugeneedle body 32 and a 7 French dilator 24, the presence of the innermember 90 can reduce the thickness of the flash channel 256 from about0.025 in. to between about 0.003 in. and about 0.005 in.

In some alternative embodiments, the distal end of the inner member 90is proximal to both the distal end of the dilator shaft 36 and to thefenestration 56 in the needle body 32 so that the fenestration 56 isbetween the distal end of the inner member 90 and the distal end of thedilator shaft 36, for example as shown in FIG. 12. In such embodiments,the flash channel 256 is formed between the inner member 90 and thedilator 24.

In some embodiments, an access device including the inner member 90 canalso include an insert 51 as described herein. The insert 51 can allowfor easier assembly of the access device, help keep the inner member 90in place, provide venting of the space between the needle body 32 andthe inner member 90 and/or the space between the inner member 90 and thedilator shaft 36, and/or help prevent blood from passing proximally outof the flash channel 256.

The space between the inner member 90 and the dilator shaft 36 can be,but need not be, in communication with the space between the innermember 90 and the needle body 32. Communication between these spaces canbe accomplished in a number of ways. In some embodiments, a proximal endof the inner member 90 can have a bias cut edge 92, and the long pointof the bias cut edge can abut the insert 51 when the insert 51 is fullyseated in the dilator hub 38, as shown in FIG. 7I. The bias cut leaves agap 96 between the remainder of the proximal edge of the inner member 90and the insert 51 to advantageously allow venting of the flash channel256 between the needle body 32 and inner member 90. In some embodiments,one or more spacer or standoff members can be disposed between portionsof the proximal end of the inner member 90 and the insert 51 to maintainone or more gaps to allow for venting. The spacer or standoff member(s)can be separate from or integrally formed with one or both of the innermember 90 and insert 51. In some embodiments, the proximal edge of theinner member 90 fully abuts and/or is integral with the insert 51. Insome such embodiments, the inner member 90 includes one or morefenestrations and/or reliefs to provide fluid communication.

In some embodiments, the access device can be assembled by sliding theinsert 51 onto the needle body 32, inserting the needle body 32 into theinner member 90, and inserting the combination of the needle body 32 andthe inner member 90 into the dilator 24. A proximal portion of the innermember 90 can extend into the dilator hub 38 when assembled as shown inFIGS. 7I and 7J. When assembled, the inner member lies within thedilator shaft 36 with its distal end fit onto the needle body 32. Thedistal end of the dilator body 36 prevents distal movement of the innermember 90 beyond the dilator 24. And the insert 51 prevents proximalmovement of the inner member 90 beyond the dilator 24.

Although this disclosure has been described in the context of certainembodiments and examples, it will be understood by those skilled in theart that the disclosure extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and obviousmodifications and equivalents thereof. In addition, while severalvariations of the embodiments of the disclosure have been shown anddescribed in detail, other modifications, which are within the scope ofthis disclosure, will be readily apparent to those of skill in the art.It is also contemplated that various combinations or sub-combinations ofthe specific features and aspects of the embodiments may be made andstill fall within the scope of the disclosure. It should be understoodthat various features and aspects of the disclosed embodiments can becombined with, or substituted for, one another in order to form varyingmodes of the embodiments of the disclosure. Thus, it is intended thatthe scope of the disclosure herein should not be limited by theparticular embodiments described above.

1. (canceled)
 2. An access device for placing a medical article within abody space, the access device comprising: a needle comprising afenestration near a distal end of the needle; a dilator disposed aboutthe needle, the dilator comprising a dilator hub and a dilator body, adistal end of the dilator body positioned against the needle and distalto the fenestration; and an inner member coaxially disposed between theneedle and the dilator, a distal end of the inner member positionedagainst the needle and distal to the dilator hub; wherein a space atleast partially defined by an outer surface of the needle and the innermember defines a flash channel in fluid communication with thefenestration to allow bodily fluid to flow from an interior of theneedle through the fenestration to the flash channel.
 3. The accessdevice of claim 2, wherein the distal end of the inner member is distalto the fenestration and proximal to the distal end of the dilator,wherein the space is at least partially between the outer surface of theneedle and an inner surface of the inner member.
 4. The access device ofclaim 2, wherein the distal end of the inner member is proximal to thefenestration, wherein the space is at least partially between the outersurface of the needle and an outer surface of the inner member.
 5. Theaccess device of claim 2 further comprising a sheath coaxially disposedabout the dilator.
 6. The access device of claim 2, wherein the needleis 21 gauge and the dilator is 7 French.
 7. The access device of claim2, wherein a thickness of the flash channel is in the range of about0.002 inches to about 0.005 inches.
 8. The access device of claim 2,wherein at least a portion of the inner member and dilator areconfigured to allow visualization of bodily fluid in the flash channel.9. The access device of claim 2, wherein the fenestration allows bloodto flow from an interior of the needle through the fenestration to theflash channel when the needle punctures a vessel
 10. An access devicefor placing a medical article within a body space, the access devicecomprising: a needle comprising a needle body and a fenestration, anouter surface of at least a portion of the needle body disposed at aradius r₁ from a central longitudinal axis of the needle; a dilatorcomprising a dilator hub and a dilator body, an inside surface of atleast a portion of the dilator body disposed at a radius r₂ from acentral longitudinal axis of the dilator, a distal end of the dilatorbody positioned against the needle body and distal to the fenestration;and an inner member comprising an inner member body having a body width,the body width being less than r₂−r_(i) such that the inner member canbe positioned in a flash channel between the needle body and the dilatorbody, a distal end of the inner member body being positioned against theneedle body and distal to the dilator hub.
 11. The access device ofclaim 10, wherein the distal end of the inner member is distal to thefenestration and proximal to the distal end of the dilator, wherein theflash channel is at least partially between the outer surface of theneedle and an inner surface of the inner member.
 12. The access deviceof claim 10, wherein the distal end of the inner member is proximal tothe fenestration, wherein the flash channel is at least partiallybetween the outer surface of the needle and an outer surface of theinner member.
 13. The access device of claim 10 further comprising asheath coaxially disposed about the dilator.
 14. The access device ofclaim 10, wherein an inner surface of at least a portion of the innermember body is disposed at an inner radius from a central longitudinalaxis of the inner member, wherein the inner radius is greater than r₁.15. The access device of claim 10, wherein an outer surface of at leasta portion of the inner member body is disposed at an outer radius from acentral longitudinal axis of the inner member, wherein the outer radiusis less than r₂.
 16. The access device of claim 10, wherein the innermember is configured to occupy more of the flash channel between theneedle and the dilator at a first position distal the fenestration thana second position proximal the fenestration.
 17. The access device ofclaim 10, wherein the inner member channels a majority of bodily fluidexiting the fenestration proximally along the flash channel.
 18. Theaccess device of claim 10, wherein an inner surface of the inner memberis disposed a distance d₂ from the outer surface of the needle, thedistance d₂ being less than one-half of the distance r₂−r₁.